Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Supplement Company Broke Drug Rules, FDA Says

A New York dietary supplement company violated drug regulations in the production and labeling of its products, the FDA said in a warning letter.

The company, Total Body Nutrition, of Edgewood, was inspected by the FDA in February and March, and the agency found several products contained 13-dimethylamylamine (DMAA), which is categorized as an unsafe additive, the letter said.

In July, the FDA checked the labeling for the firm’s Omega-3 fish oil and website advertising for its Total Estro (3,3 Diindolymethane) and found the company claimed they could treat or cure disease, which subjects them to regulation as drugs.

The claims for Omega-3 Fish Oil included its effectiveness in reducing the risk of heart attack, breast and prostate cancer, depression and ADHD in children, the letter said, as well as mitigating inflammation and pain. The firm touted Total Estro (3,3 Diindolymethane) as an anti-cancer treatment.